Allentown, PA • North Wales, PA (610) 435-9575

Current Clinical Research Activities

Eileen A. Taff, MSN, RN, NE-BC, CCRC

Marcie A. Taff, RN

A research study is a scientific way to improve or develop new methods of health care. Studies are designed to answer specific questions on how to prevent, diagnose, or treat diseases and disorders. Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people.

Women's health research plays an important role at The Institute for Female Pelvic Medicine & Reconstructive Surgery. As a result of The Institutes national reputation and expertise, surgical instrument and pharmaceutical companies bring their new product developments to the Institute. Under the medical advisement and guidance of our physicians, many research protocols are available at the Institute. We take great pride in continuously updating you on all the new and exciting research opportunities. All of the clinical research trials have full Investigational Review Board (IRB) approval and are conducted by experienced research personnel, assuring good clinical practice.

All mesh products are FDA approved and are not experimental or investigational

Research Studies Conducted in our Allentown Office

522 Post Market Studies – Surgical Prolapse Procedure

The studies listed below are similar in regards to treatment but the products are different and have been chosen by your physician based on this decision on your medical history and examination. Restorelle is the study which is still open to enrollment, the remaining studies are in follow up status.

The main purpose of these research studies is to gather information on prolapse repair treatments for your Pelvic Organ Prolapse (POP) by either using a mesh or a non-mesh surgical procedure. The studies are designed to follow patients through the standard of care procedures that would be occurring with or without the study. The objective is to collect information enter it into a data base where all studies can be compared equally to one another. Your information will be protected by HIPAA guidelines and nothing will be shared without your knowledge or permission.

Most research studies follow the same standard of care. You will be asked to return to the hospital or the office for your follow-up examinations and care at 2, 6, 12, 18, 24, and 36 months after the procedure. During these visits you will undergo a pelvic exam, urine test and you will fill out brief questionnaires. We estimate that each follow-up visit will last less than 1 hour.

Restorelle Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse (Sponsored by Coloplast, Inc.) Enrolling

Eligibility: Women diagnosed with a uterine prolapse and are scheduled for surgery to correct the prolapse. Information from patients having Mesh will use the Restorelle Procedure Repair System.

522 Post Market Studies - Surgical Sling Procedure

Women diagnosed with stress urinary incontinence and surgical treatment with an incontinence sling is an appropriate treatment option for you. All the incontinence slings used in this trial have been cleared for marketing by the U.S. Food and Drug Administration (FDA), meaning that the FDA allows the slings to be sold and used by doctors.

A Post-Market Evaluation of the Altis® Single Incision Sling System versus Transobturator or Retropubic Mesh Sling in the Treatment of Female Stress Urinary Incontinence. Study Name: Altis 522 Study (Sponsored by Coloplast) Enrolling

The study lasts for approximately 3 years. You will see your doctor prior to your surgery (baseline visit), at the time of surgery, and at required study visits at 6 months, 12 months, 18 months, 24 months and 36 months. In this trial, you might have more frequent visits after surgery than you would if you were not participating in the trial. At each study visit, certain tests will be conducted and you will be required to respond to questionnaires.

Transvaginal Imaging Study

A Clinical Validation Study Transvaginal Imaging (Sponsored by Artann Labs) Enrolling

Eligibility: Women diagnosed with a uterine prolapse with or without surgical treatment. An ultrasound will be performed at different intervals based on the sub study that you are enrolled in. A payment for time and travel is available.

Studies for treating Stress Incontinence

Use of the Vesair Bladder Control System in the Treatment of Post -Menopausal Female Subjects with Stress Urinary Incontinence (Sponsored by Solace Therapeutics, Inc) Enrolling

Eligibility: Post – Menopausal Women with Stress Incontinence who have experienced at least 12 months of bladder leaks. The Vesair Bladder Control Balloon will be inserted and monitored for 12 months. A payment for time and travel is available.

Studies closed to enrollment - Patients in follow up status

Evaluation of the Use of Transvaginal Resorbable Biologic Mesh as Compared to Traditional Non-Mesh Surgical Repair for Treating Pelvic Floor Disorders (Sponsored by ACELL)

A Prospective, Safety and Efficacy Cohort Study of Elevate® Anterior and Apical Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse Repair Protocol # PR1205 (Sponsor by AMS)

A Prospective, Safety and Efficacy Cohort Study of Elevate® Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse Repair Protocol # PR1206 (Sponsored by AMS)

Exair® Prolapse Repair System versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse (Sponsored by Coloplast, Inc)

A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of Uphold LITE vs. Native Tissue for the Treatment of Women with Anterior/Apical Pelvic Organ Prolapse. Uphold LITE Study (Sponsored by Boston Scientific Corporation)

An Investigation of the TReatment of FecAl IncontiNence using the TOPASTM Sling System FOR WoMen (TRANSFORM)

Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study Clinical Investigational Plan (CIP)

Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices (CAPTURE Registry)

Complete Continence as Primary Metric for Onabotulinumtoxin A Overactive Bladder Treatment Success (Sponsored by ALLERGAN)

Medication Studies

Complete Continence as Primary Metric for Onabotulinumtoxin A Overactive Bladder Treatment Success (Sponsored by ALLERGAN)

The purpose of this study is to evaluate the efficacy and safety of BOTOX compared to placebo in achieving 100% reduction in urinary incontinence.

Eligibility: Women with Overactive Bladder (OAB) whose symptoms have not been adequately managed with medication. Maximum enrollment period is 51 weeks

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